Six months ago, Angela Simmons Alvarez got a letter in the mail from her insurer, asking her to please stop taking a drug she has relied on for nearly 20 years.
She's not alone.
Health insurers have been increasingly cracking down on members' use of high-cost biologic drugs, with UnitedHealthcare, Aetna and Cigna unveiling policies this year that force patients to switch to biosimilars or restrict the drug dosage an individual can receive.
"Their letter basically says talk to your doctor and if they agree, then you can go on with the other ones. It does not say you must take one of these other ones," said Simmons Alvarez, who suffers from ulcerative colitis and is insured through Cigna. "But in practice, that's exactly what they're doing."
Some of the biosimilars insurers have added to their preferred drug list cost more than their originator, leaving Simmons Alvarez wondering why she's being told that moving to Avsola will result in a massive cost savings. Cigna has said that switching to a biosimilar will save patients at least 10% on their medications in the short-term.
Although generic medicines are common, biosimilars differ in a key respect from unbranded versions of chemical pharmaceuticals. Generic manufacturers can precisely recreate chemical drugs, making them virtually indistinguishable from the original brand name products. Biologics, however, are grown from living organisms like cell tissue, bacteria or proteins, which means they can mimic the original medicines but not exactly duplicate them.
There are nearly 30 biosimilars that have been approved by the Food and Drug Administration (FDA) today, although none have been approved as directly "interchangeable" with Remicade, which is used on patients with psoriasis, arthritis and gastrointestinal conditions such as Crohn's disease. The FDA has found that biosimilars can result in clinically similar outcomes among patients compared with their originators.
In 2019, the federal agency approved Amgen's Avsola, after a randomized, double-blind comparative clinical study found "no clinical meaningful differences" between the efficacy of the biosimilar and Remicade. The federal agency approved Pfizer's biosimilar Inflectra in 2016, recommending the drug for patients suffering from gastrointestinal diseases "who have shown an inadequate response to conventional therapy."
Smaller studies have found some variance in efficacy between biosimilars and originators, and the American Gastroenterologists Association recommends biosimilars for patients who have not started an originator drug yet, or whose condition is stable and have been responding well to an originator for at least 18 months.
Drug manufacturers Pfizer and Amgen both say on their websites that switching to a biosimilar must be a decision between a physician and her patients. But UnitedHealthcare and Cigna have mandated patients stop taking Remicade through their new non-medical switching policies.
As of April 1, Minnetonka, Minn.-based UnitedHealthcare required patients to switch from Remicade to two biosimilars on a rolling basis as their prior authorizations expired. Pregnant women, children under 16 years old and patients who have previously tried—and failed to respond—to these therapies are exempt from the policy. In some instances, physician appeals on behalf of their patients will also be considered, UnitedHealthcare said.
"We evaluate each brand name biologic and its biosimilar one-by-one to ensure comparable clinical value and efficacy, and will prefer the lower cost option in order to make care more affordable for our members, clients and consumers," a spokesperson wrote in an email.
As of July 1, Cigna required all patients over 6-years-old to swap two biosimilars for Remicade. To soften the news, the Bloomfield, Conn.-based insurer offered patients a $500 prepaid gift card, a practice the American Medical Association's House of Delegates voted to oppose shortly after the formulary change was announced.
While some physicians called Cigna's move a bribe, at least the insurer is offering to share its cost savings with patients, although offering the medically appropriate treatment is the best strategy for cutting healthcare costs, said Dr. Sandeep Singh, an inflammatory bowel disease specialist at Stanford University who engaged in conversations with UnitedHealthcare and Cigna on behalf of the AGA.
"This will be the largest experiment in the world, when these insurers do it," Singh said. "Patients are coming to us with questions, 'Why is this happening? What is the impact on my health going to be? And is this a good idea?' Unfortunately, I don't have the information to provide the guidance."
In May, Aetna also unveiled a policy that began restricting doses for biosimilar Infliximab that were above 5mg. A spokesperson said this dosage is consistent with FDA recommendations and "there are instances when we do approve higher doses, based on clinical quality guidelines."
Across all insurers, Singh said the new restrictions are short-sighted moves aimed at cutting drug costs. A 2019 study from the Pacific Research Institute estimated that biosimilars save commercial insurers $136.8 million annually and, if their reach is expanded to make up 75% of prescriptions, the U.S. healthcare system would save nearly $7 billion each year.
"Fast forward to next year, and the insurance company has a better contract with the originator instead of a biosimilar. Are they going to ask us to switch year after year?" Singh said.
Singh said he started conversations with UnitedHealthcare around February, and that the discussion resulted in some flexibility on the insurer's part—namely, they now will consider physicians' exception requests. Cigna, on the other hand, "basically chose to ignore everything we suggested," Singh said, unveiling a blanket policy for nearly all of its enrollees. Because Aetna's policy is so new, he has not spoken with Aetna representatives yet. Across all the insurers, Sandeep said he has received no notification of the policies from payers, instead finding out about formulary restrictions from his patients.
These companies aim to take advantage of individuals' preoccupation with the COVID-19 pandemic, because "they know people are busy and occupied with other responsibilities, and they will be able to implement these policies without much pushback," Singh said. Their announcements also come just before biosimilar developers prepare to launch low-cost rivals to Humira—Abbvie's psoriasis remedy that happens to be the world's best selling drug—in 2023. Insurers' new policies could signal that they plan to be more assertive in their upcoming negotiations with drug manufacturers, Singh said.
"The 100% change in policy reflects an overly aggressive stance that must be driven by something," he said.
He said the formulary changes create an administrative nightmare for infusion centers, since now many have to stock multiple versions of similar drugs, which result in increased inventory cost and decrease infusion centers' ability to negotiate more bulk pricing discounts with drug companies. Singh said these restrictions will not result in long-term savings for insurers, since there is so little data around how these policies will translate into health outcomes for patients, which could be more complicated.
In Angela Simmons Alvarez's case, the last time she stopped taking Remicade, she said she lost the ability to walk independently, suffered gastrointestinal issues and her vision failed.
"I am extremely anxious because I've had some severe issues, and I'm scared," Simmons Alvarez said.
After calling Cigna four times, Simmons Alvarez has received a 90-day, temporary authorization to continue infusions of Remicade, which she has been taking for nearly 20 years. Her physician has also submitted multiple appeals on her behalf, and the self-insured employer who she receives coverage through has also reached out to Cigna about the policy change, she said.
But going through her medical health records and explaining her family's health history with the insurance company has been traumatic. Four years ago, Simmons Alvarez's sister died from ulcerative colitis.
"I'm at home with my kids," she said. "I've been very active in the process with my vendors and insurance staff, I have to try to find time away to research and to make calls. Not everybody can do that. It's very traumatic and very frustrating."